The oral direct factor Xa inhibitor, edoxaban, may be as effective as warfarin for the prevention of symptomatic recurrent venous thromboembolism (VTE), with less clinically relevant bleeding, for patients with cancer, a study published in the journal The Lancet Haematology has shown.1
Investigators conducted a prespecified subgroup analysis and a post-hoc analysis of this Hokusai-VTE trial, a double-blind, double-dummy, multicenter study conducted between 2010 and 2012, for which 771 patients with cancer and acute symptomatic deep-vein thrombosis, or acute symptomatic pulmonary embolism, were recruited.
Patients were randomly assigned to receive edoxaban 60 mg once daily or warfarin for at least 3 months up to 12 months. All participants initially received enoxaparin or unfractionated heparin for at least 5 days.
Recurrent VTE occurred in 4% of the 378 patients who received edoxaban, compared with 7% of the 393 patients who received warfarin (hazard ratio [HR], 0.53; 95% CI, 0.28-1.00; P = .0007). Edoxaban was not non-inferior to warfarin.
The study demonstrated that 12% of patients who were given edoxaban experienced clinically relevant bleeding, versus 19% of those who received warfarin (HR, 0.64; 95% CI, 0.45-0.92; P = .017).
Researchers found that 3% of patients in each group had major bleeding (HR, 0.80; 95% CI, 0.35-1.83).
Future clinical trials should compare edoxaban with low-molecular-weight heparin for the treatment of VTE in this high-risk population, the authors conclude.
1. Raskob GE, van Es N, Segers A, et al. Edoxaban for venous thromboembolism in patients with cancer: results from a non-inferiority subgroup analysis of the Hokusai-VTE randomised, double-blind, double-dummy trial. Lancet Haematol. 2016 Jul 1. doi: 10.1016/S2352-3026(16)30057-6 [Epub ahead of print]